Hydrophilic medical products and hydration mediums for hydrating the same

ABSTRACT

Hydration mediums for hydrating hydrophilic coatings of urinary catheters and urinary catheter products containing such hydration mediums. Methods for making urinary catheter products having hydration mediums.

The present application is a continuation of U.S. patent applicationSer. No. 17/055,973, filed Nov. 16, 2020, which is the U.S. NationalStage of International Application No. PCT/US2019/032906, filed May 17,2019, which claims the benefit and priority to U.S. ProvisionalApplication No. 62/672,755, filed May 17, 2018, U.S. ProvisionalApplication No. 62/699,993, filed Jul. 18, 2018, U.S. ProvisionalApplication No. 62/739,449, filed Oct. 1, 2018, U.S. ProvisionalApplication No. 62/770,275, filed Nov. 21, 2018, U.S. ProvisionalApplication No. 62/821,268, filed Mar. 20, 2019, U.S. ProvisionalApplication No. 62/821,284, filed Mar. 20, 2019, and U.S. ProvisionalApplication No. 62/842,318, filed May 2, 2019, all of which are herebyincorporated herein by reference.

DESCRIPTION Technical Field

The present disclosure generally relates to hydrophilic medical deviceproducts and hydration mediums for hydrating or wetting such medicaldevices. More particularly, the present disclosure generally relates tohydrophilic urinary catheter products and hydration mediums forhydrating such hydrophilic urinary catheters.

Background

Several different devices in different industries are required to behydrated prior to use and/or stored in a hydrated condition. In manyinstances, such devices are stored or packaged in a hydration medium,such as a liquid hydration medium. Liquid hydration mediums may be, butare not limited to, water or aqueous solutions.

One type of device wherein it may be advantageous to package the devicein a hydrated stated and/or in a hydration medium is a medical devicethat is made from a hydrophilic material, such as a hydrophilicallycoated urinary catheter. In several applications, a coating ofhydrophilic material is applied to the surface of a device to provide alubricious surface. When the hydrophilic material is wetted or hydratedwith a hydration medium, the hydrophilic material becomes extremelylubricous. The hydration medium may be, for example, liquid or vaporwater or an aqueous solution. In the field of insertable medicaldevices, the lubriciousness of the hydrophilic coating can easeintroduction of the device into the body and aids in reducing pain anddiscomfort associated with such introduction.

In devices that are required to be stored in and/or hydrated with ahydration medium, the product may include a device that is packaged inan assembly with the hydration medium, such that the device is incontact with the hydration medium. In such packaging assemblies, if theassembly lacks a sufficient amount of hydration medium, the device maynot be sufficiently hydrated for use. Even if a sufficient amount ofhydration medium is placed in the package assembly, the packaging may besuch that there is a risk that the device may not be evenly hydrated orthat the hydration medium does not migrate in the package to hydrate theentire device. Alternatively, if too much hydration medium is placed inthe package, there may be an increased risk of spillage when the packageis opened. Additionally, too much hydration medium added to the packagemay result in some loss in efficiency of costs due to the costassociated with the excess hydration medium.

Therefore, there remains a need for package products that containhydration mediums, methods of hydrating devices within a package with ahydration medium, and hydration mediums for use in such products andmethods.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In one aspect, a hydration medium for hydrating or wetting a device,wherein the hydration medium comprising a hydration foam.

In another aspect, a product including a package containing the deviceand a hydration medium comprising a hydration foam.

In another aspect, a method of making a product that includes placing adevice within a package, and placing a hydration medium into thepackage, wherein the hydration medium comprises a hydration foam.

In another aspect, a method of making a product includes mixing a gasand a hydration liquid to form a gas and liquid mixture. The gas andliquid mixture are formed into a foam, and the foam is depended into amedical device assembly. The foam hydrates the medical device.

In yet another aspect, a system for making and dosing hydration foaminto a medical device assembly includes a supply of hydration liquid, asupply of gas, and a homogenizer in communication with the supply ofhydration liquid and the supply of gas, wherein the homogenizer isconfigured to mix the hydration liquid and gas and to form a foam fromthe hydration liquid and gas. The system includes a dispensing memberconfigured to dispense the foam into a medical device assembly.

In another aspect, a method of making a urinary catheter productincludes placing a hydrophilic catheter within a package, dispensing afirst reactant, a second reactant and at least one liquid into thepackage, and reacting the first reactant with the second reactant toproduce a gas that forms a hydration foam with the liquid, wherein thehydration foam hydrates a hydrophilic material of the hydrophiliccatheter.

In a further aspect, a packaged urinary catheter includes a packagehaving a sealed cavity. The sealed cavity contains a hydrophiliccatheter, a hydration liquid, and a first reactant and a secondreactant, wherein when the first and second reactants react, a gas isformed and the gas forms a foam with the hydration liquid.

In yet another aspect, a urinary catheter assembly includes a cathetershaft, a hydrophilic coating on the catheter shaft, wherein thehydrophilic coating is in a hydrated state. The assembly furtherincludes a layer comprising mucilage disposed over the hydrophiliccoating.

In another aspect, a device assembly includes a package containing thedevice, the device including a hydrophilic material, and a hydrationmedium comprising mucilage located within the package.

In another aspect, a method of making a device assembly includesdeploying a hydration medium comprising mucilage into a packagecontaining a catheter, the catheter having a hydrophilic material, andenclosing the catheter within a package.

In yet another aspect, a hydrophilic medical assembly includes a packagehaving a cavity. The cavity contains a hydrophilic medical deviceincluding a lubricious hydrophilic material, a hydration fluid, and adeep eutectic liquid.

In another aspect, a hydrophilic urinary catheter assembly includes apackage including a cavity. The cavity contains a urinary catheterhaving a lubricous hydrophilic coating, and a hydration fluid thatcomprises a deep eutectic liquid.

In another aspect, a hydrophilic urinary catheter assembly includes apackage including a cavity. The cavity contains a urinary catheterhaving a lubricious hydrophilic coating wherein the coating includes adeep eutectic liquid.

In another aspect, a hydrophilic medical device assembly includes apackage including a cavity. The cavity contains a hydrophilic medicaldevice, a hydration fluid, and antifreeze protein.

In yet another aspect, a hydrophilic medical device assembly includes apackage including a cavity. The cavity contains a hydrophilic medicaldevice, a hydration fluid, and corn syrup.

In another aspect, a hydrophilic medical device assembly includes apackage including a cavity. The cavity contains a hydrophilic medicaldevice, a hydration fluid, and a cryoprotectant.

In another aspect, a urinary catheter assembly includes a cathetershaft, a hydrophilic coating on the catheter shaft, and a hydrationmedium comprising oil disposed over the hydrophilic coating.

In another aspect, a device assembly includes a package containing thedevice, the device including a hydrophilic material in a hydrated state,and a layer comprising oil disposed over the hydrophilic material.

In yet another aspect, a method of making a device assembly includesapplying an oil layer to a hydrophilic material of a catheter, andenclosing the catheter within a package.

In yet another aspect, a hydration fluid or layer includes oil in anamount between 0.01 wt % to 5 wt % of the fluid or layer, water in anamount between 80 wt % to 98.8 wt %, polyol in an amount between 1 wt %to 10 wt %, and surfactant in an amount between 0.01 wt % to 5 wt %.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 is a perspective view of a catheter assembly in accordance withthe present disclosure;

FIG. 2 is a perspective view of one embodiment of an insertion aid ofthe assembly of FIG. 1;

FIG. 3 is a perspective view of another embodiment of an insertion aidof the assembly of FIG. 1;

FIG. 4 is a schematic view of one embodiment of a method of making ahydrophilic sleeved catheter assembly in accordance with the presentdisclosure;

FIG. 5 is a top plan view of one embodiment of a packaged medical deviceproduct containing a medical device and a hydration medium in accordancewith the present disclosure;

FIG. 6 is a perspective view of the packaged medical device of FIG. 5shown with the package in a partially open configuration;

FIG. 7 is a cross-sectional view of the medical device package of FIG.5;

FIG. 8 is a cross-sectional view of the catheter shaft shown in FIG. 1;

FIG. 9 is a schematic cross-sectional view of the catheter shaft ofFIGS. 1 and 8;

FIG. 10 is a schematic cross-sectional view of the catheter shaft ofFIGS. 1 and 2;

FIG. 11 is a schematic illustration of one embodiment a hydration foamforming and dispensing system;

FIG. 12 is a schematic illustration of another embodiment of a hydrationfoam forming and dispending system;

FIG. 13 is a schematic illustration of another embodiment of a hydrationfoam forming and dispending system;

FIG. 14 a schematic illustration of another embodiment of a hydrationfoam forming and dispending system;

FIG. 15 is a schematic illustration of catheter package receivingsolutions during the packaging process, wherein the solutions form ahydration foam;

FIG. 16 is a front plan view of the catheter package of FIG. 15 showingthe hydration foam occupying the cavity of the package;

FIG. 17 is a front plan view of another embodiment of a catheter packagethat includes solutions for forming a hydration foam, wherein one of thesolutions in contained in a compartment within the package;

FIG. 18 is a front plan view of the catheter package of FIG. 17, showingcompartment being in an opened state;

FIG. 19 is a front plan view of the catheter package of FIG. 17 showingthe hydration foams occupying the cavity of the catheter;

FIG. 20 is another embodiment of a catheter package that includesreactants to form a hydration foam;

FIG. 21 is a front plan view of a catheter assembly shown with theprotective cap removed;

FIG. 22 is a front view of the catheter assembly and a delivery system,showing hydration foam being delivered into the sleeve of the assembly;

FIG. 23 is a front view of a packaged catheter product and a deliverysystem, showing hydration foam being delivered into the sleeve of theassembly;

FIG. 24 is a front view of the catheter assembly and a delivery system,showing hydration foam being delivered into the sleeve of the assembly;

FIG. 25 is a front view of a packaged catheter device and a deliverysystem, showing hydration foam being delivered into the sleeve of theassembly;

FIG. 26 is a front plan view of a catheter assembly;

FIG. 27 is a front plan view of the catheter assembly of FIG. 26, shownwith the protective cap removed and foam within the sleeve;

FIG. 28 is a front plan view of a packaged catheter product;

FIG. 29 is a front plan view of the packaged catheter product of FIG.28, shown with the package in opened and foam within the package;

FIG. 30 is a front plan view of a catheter assembly;

FIG. 31 is a front plan view of the catheter assembly of FIG. 30, shownwith the protective cap removed and foam within the sleeve;

FIG. 32 is a front plan view of a packaged catheter device;

FIG. 33 is a front plan view of the packaged catheter device of FIG. 32,shown with the package opened and foam within the package;

FIG. 34 is a front plan view of a catheter assembly;

FIG. 35 is a front plan view of the catheter assembly of FIG. 34, shownwith the protective cap removed and foam within the sleeve;

FIG. 36 is a front plan view of a packaged catheter product;

FIG. 37 is a front plan view of the packaged catheter product of FIG.36, shown with the package in opened and foam within the package;

FIG. 38 is a front plan view of a catheter assembly;

FIG. 39 is a front plan view of the catheter assembly of FIG. 38, shownwith the protective cap removed and foam within the sleeve;

FIG. 40 is a front plan view of a packaged catheter product; and

FIG. 41 is a front plan view of the packaged catheter product of FIG.40, shown with the package in opened and foam within the package.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific embodiments and featuresdisclosed herein are not to be interpreted as limiting the subjectmatter as defined in the accompanying claims.

The present disclosure is directed to hydrophilic medical products thathave a package containing a hydrophilic medical device and a hydrationmedium that hydrates the hydrophilic material of the medical device. Thehydrophilic materials may be materials that become lubricious whenhydrated, activated or wetted with a hydration medium. The lubricioushydrophilic material may include any suitable hydrophilic polymer suchas, polyvinylpyrrolidone, polyethylene oxide, polyurethanes, homo- andcopolymers of acrylic and methacrylic acid, polyvinyl alcohol, etc. Thehydrophilic material may be a coating on the surface of the medicaldevice. The medical devices may include shafts or tubes that may beinserted into and advanced within a lumen of a body, such as a urethra,anus, esophagus, or fallopian tube. Such medical devices include urinarycatheters, fecal catheters. endovascular catheters, endoscopes,exploratory and biopsy devices, etc. While some of the embodiments setforth below may be described in the context of urinary catheters, thedisclosure is not limited to such and the features disclosed herein maybe applicable to any medical tubing that is inserted into a body lumen.

The present disclosure is also directed to hydration mediums forhydrating medical devices. The hydration medium may be a hydrationliquid that includes a liquid, such as water, along with various othercomponents. For example, the hydration medium of the present disclosureincludes liquid water and, optionally, one or more of a surface tensionreducing agent, mucilage, deep eutectic liquid, oil and osmolalityincreasing agents. The hydration medium may include other additives andagents as well. Any of the hydration mediums disclosed herein may beused in a foamed or unfoamed state.

Optionally, the hydration medium may be foamed to produce a hydrationfoam or mousse which may be used to hydrate or wet a device or product.The hydration foam may directly contact the hydrophilic material tohydrate it. The hydration foam includes a mass of gas bubbles formed onor in liquid. Additionally, the creation or formation of the hydrationfoam may occur at any of the various stages from manufacture to use,depending on the design and use of the medical device. While any of thehydration mediums disclosed herein may be foamed or formed into a foam,depending on the desired use, the hydration mediums disclosed hereinalso may be employed in an unfoamed state.

Optionally, the hydration medium may include a mucilage. For example,the hydration medium may include water and mucilage, as well as otheradditives and agents. When a mucilage containing hydration medium isemployed, it hydrates the hydrophilic material of the medical device andmay form a mucilage layer over the hydrophilic material. For example,when the hydrophilic device is a hydrophilically coated urinarycatheter, the hydration medium hydrates the hydrophilic coating andforms a layer containing mucilage over the hydrophilic coating. As willbe disclosed in more detail below, the layer of mucilage may havethixotropic properties wherein the layer is thick and viscous under astatic condition, and then, becomes less viscous and flows when shearedor otherwise stressed. That is the hydration medium or layer formedtherefrom may have a semi-solid or gel-like state and when under stresshave more of a liquid state. A hydration medium containing mucilage maybe employed in a foamed or unfoamed state.

Optionally, the hydration medium may include a deep eutectic liquid.Deep eutectic liquids can include deep eutectic liquids that are addedto the hydration medium and/or and compounds that are added to thehydration medium interact to form a deep eutectic liquid. The hydrationmedium may include water and a deep eutectic liquid, as well as otheradditives or agents. Deep eutectic liquids are a mixture or blend of twoor more compounds wherein the melting point of the deep eutectic liquidis substantially lower than the melting points of the individualcompounds. Deep eutectic liquids have been described as the result ofintermolecular hydrogen bonds between the compounds, which at a certainmolar ratio leads to a strong depression in the melting point ascompared to that of the individual components. Deep eutectic liquids aretypically liquid at room temperature (˜23° C.). A hydration mediumcontaining a deep eutectic liquid may be employed in a foamed orunfoamed state.

Optionally, the hydration medium may include oil. For example, thehydration medium may include water and oil, as well as other additivesand agents. When an oil containing hydration medium is used, it hydratesthe hydrophilic material of the medical device and may form a layercontaining oil over the hydrophilic material. A hydration mediumcontaining oil may be employed in a foamed or unfoamed state.

Turning now to FIG. 1, this figure illustrates one embodiment of acatheter assembly 10 in accordance with present disclosure, which may bepart of a catheter product. The catheter assembly 10 includes anelongated catheter tube 12 having a proximal end portion 14 and a distalend portion 16. The proximal end portion 14 of the catheter tube 12 issuitable for insertion into a lumen or a passageway of the body, such asthe urethra. The proximal end portion 14 may include drainage holes oreyelets 18 for draining urine from the bladder. A drainage member 20 maybe associated with the distal end portion 16 of the catheter tube 12.The catheter tube 12 includes an outer hydrophilic surface that becomeslubricious when hydrated or activated. The outer surface may be, forexample, any suitable hydrophilic coating.

The catheter assembly 10 also includes a sleeve 22, which may be aprotective or barrier sleeve, that has a proximal end portion 24 and adistal end portion 26. The sleeve 22 surrounds at least a portion of thecatheter tube 12 to separate and enclose the portion of the cathetertube 12 from the outside environment. In other words, the protectivesleeve 22 defines an internal cavity in which the catheter tube 12 maybe located. In one embodiment, the sleeve 22 extends over the length ofthe catheter tube 12. Optionally, an insertion aid 28 may be located atthe proximal end portion 24 of the sleeve 22. When an insertion aid 28is present, the proximal end portion 24 of the sleeve 22 may be attachedto a barrel 30 of the insertion aid 28, by for example, welding oradhesive. The distal end portion 26 of the sleeve 22 may be attached tothe drainage member 20 or the catheter tube 12. An insertion aid may beused with any of the catheter assemblies disclosed herein.

The sleeve 22 may be made of a flexible material which may be vaporpermeable or vapor impermeable, depending on the desired use andpackaging. The material of the sleeve 22 also may be liquid impermeableor liquid permeable. The sleeve 22 may be formed of any of a variety ofthin, flexible polymeric film materials, such as polyethylene,plasticized PVC, or polypropylene, but elastomeric film materials suchas polyurethane, and particularly elastomeric hydrogel materials, may beparticularly suitable. The thickness of the film from which the sleeve22 is formed may vary considerably depending on factors such asstretchability and flexibility of the material selected but, in general,the thickness may fall within the range of about 10 to 150 microns,preferably about 13 to 50 microns.

Referring to FIGS. 1, 2 and 3, these figures illustrate exemplaryembodiments of the insertion aids. In FIGS. 1 and 2, the insertion aid28 includes a proximal end portion 32 that defines an introducer tip 34.The introducer tip 34 has a proximal end opening 36 defined by one ormore slits between one or more flexible petals 38. The petals 38 maymove, bend and/or resiliently deform from the generally closedconfiguration shown in FIGS. 1 and 2 to an open configuration (notshown) to allow for advancement of the catheter tube 12 therethrough.The distal end portion of the insertion aid 28 includes a cylindrical orbarrel portion 30 that has an opening 40 for receiving the catheter tube12. The insertion aid 28, optionally, also may include an intermediateflange 42 that may contact the user around the urethral opening and actas a stop to limit the insertion of the introducer tip 34.

Turning to FIG. 3, in this embodiment the introducer aid 28 a is a port29 a that includes a flange 42 a surrounding an opening 34 a. Thecatheter tube 12 advances through opening 34 a for insertion into theurethra. The distal end portion of the port 29 a includes a cylindricalor barrel portion 30 a that has an opening 40 a for receiving thecatheter tube 12.

Turning back to FIG. 1, the introducer aid 28, optionally, may becovered by a removable protective cap 44. The removable protective cap44 covers the introducer aid 28 and may protect the introducer aid 28from contacting surfaces and objects prior to use.

To use the catheter assembly 10, the user opens and removes the catheterassembly 10 from an outer package, which may be similar to the packageshown in FIGS. 5 and 6. For example, the user opens the package andgrasps the catheter tube 12 through the protective sleeve 22 to handleand manipulate the catheter assembly 10. The user removes protective cap44, if one is present. If the catheter assembly 10 includes the optionalinsertion aid 28 shown in FIG. 2, then the user inserts the introducertip 34 into the urethra. If the catheter assembly 10 includes theoptional insertion aid 28 a shown in FIG. 3, then the user aligns theopening 34 a of the port 29 a with the urethral opening. The user thengrasps the catheter tube 12 through the sleeve 22 and advances thecatheter tube 12 through the introducer aid 28/28 a, if present, andinto and through the urethra until the eyelets enter the bladder. If thecatheter assembly 10 does not includes an insertion aid, then the usergrasps the catheter tube 12 through the sleeve 22 and advances the tipof the catheter tube 12 out of the open end of the sleeve 22 and intothe urethra. When the eyelets enter the bladder, urine flows through theeyelets and catheter tube 12 to drain the bladder.

In one method of making a sleeved hydrophilic catheter wherein thehydrophilic surface is in an activated or hydrated state, such as thosedescribed above, the method includes delivering a hydration medium intothe internal cavity of the sleeve of the catheter assembly. While in thesleeve, the hydration medium contacts the hydrophilic surface of thecatheter to at least partially hydrate or activate the hydrophilicsurface. The hydration medium may be any of the hydration mediumsdiscussed herein. The hydration medium may be a foamed hydration mediumor an unfoamed hydration medium. When a foamed hydration medium isemployed, the foam may be configured so that after a period of time, thefoam will coalesce and collapse (bubbles break or dissipate) and thevolume of the foam will decrease or the hydration medium will becomeunfoamed. Optionally, the foamed hydration medium may be configured asto not coalesce. Furthermore, the foamed hydration medium may be suchthat a coalesced hydration medium refoams from agitation, such as byshaking the catheter product.

Turning now to FIG. 4, this figure provides a schematic representationof a method that includes an injection system 52 for injecting ahydration medium into the sleeve of a catheter assembly 10. The catheterassembly 10 may be docked or otherwise operatively connected to ahydration medium delivery system or machine 52. The delivery system 52may include a source of hydration medium 56, which could be a reservoiror tank 54 containing an amount of hydration medium 56. The system mayinclude a conduit 58 one end 60 of which is connected to the source ofhydration medium 56 and the end 62 of which is configured to beconnected to the catheter assembly 10 so that hydration medium 56 can bedelivered into and the interior cavity of the sleeve 22. For example,the end 62 of the conduit 58 may include a nozzle 64 configured to bereleasably connectable to the sleeve 22 or the introducer aid 28, if oneis present. The system also includes a pump or metering valves or otherelement 66 for moving/pumping hydration medium 56 so as to injecthydration medium into the sleeve 22.

As discussed above, the method of forming the sleeved activatedhydrophilic catheter may include injecting a hydration medium into theinterior cavity of the sleeve, wherein the hydration medium comes intocontact with the outer hydrophilic surface of the catheter tube. Whenthe hydration medium is a foam medium, foam may also serve as a visualindicator by human or electronic eye to confirm that the hydrationmedium has been injected into the sleeve. After the hydration medium 56has been injected, the nozzle 64 is undocked and the protective cap 44,if one is present, is placed on or refitted onto the insertion aid 28.The catheter assembly 10 is then placed within a package (such as apackage shown in FIGS. 5 and 6) and the package is sealed. The packagemay then be submitted to sterilization by e-beam or gamma radiation.

In one embodiment, the package may be made of a gas impermeable andliquid impermeable material, such as a polymer and aluminum laminate.Furthermore, the package may be of the type that has a vapor atmosphereor 100% relative humidity within the seal package. For example, thepackage may include therein a water compartment that is at least partialdefined by a vapor permeable, liquid impermeable material. The waterwithin the compartment may produce a water vapor that permeates throughthe vapor permeable, liquid impermeable material to create and/ormaintain a hydration environment within the package. Additionally, whenthe catheter assembly is placed in a package having a vapor atmosphere,the sleeve may be vapor permeable to allow vapor to come into contactwith the partially or substantially hydrated hydrophilic surface of thecatheter tube. This may assist in maintaining the hydrophilic surface inan activated or hydrated state during storage and distribution.

In another embodiment, the sleeve may be liquid permeable such thatliquid outside of the sleeve permeates through the sleeve to hydrate thehydrophilic medical device. In such an embodiment, the hydration medium,such as a form hydration medium, may be placed in the package outside ofthe sleeve. The hydration medium migrates through the sleeve andhydrates the hydrophilic medical device.

Turning now to FIGS. 5-7, these figures illustrate a medical devicepackage 100 for containing a medical device 112, such as the illustratedcatheter, and a hydration medium 130 (FIG. 7). The package, optionally,could also contain a gripping aid, such as a tubular gripper positionedaround the catheter shaft. Optionally, in any of the catheters discloseherein, the distal end of the catheter may be connected to a collectionbag. In such embodiment, the collection bag may be contained in thepackage with the catheter. The hydration medium may be any of thehydration mediums disclosed herein, and the hydration medium may be in afoamed or unfoamed state. The medical device may be any suitable medicaldevice. In the illustrated embodiment, the medical device is ahydrophilic catheter.

The package 100 may be any suitable package for holding the device. Forexample, the package may be a tear open package, such as a side tearopen package, or a peel open package. In the illustrated embodiment, thepackage 100 includes a front sheet 114 and a back sheet 115 (FIGS. 6 and7). The front sheet 114 includes an inner surface 116 facing the backsheet 115, an outer surface 117 facing the ambient atmosphere, a topedge 118, bottom edge 119 and opposed first and second side edges 120and 121. Referring to FIGS. 6 and 7, the back sheet 115 includes aninner surface 122 facing the front sheet 114, an outer surface 128facing the ambient atmosphere, a top edge 123, bottom edge (not shown)and opposed first and second side edges 124 and 125.

The front sheet 114 and back sheet 115 may be made from a liquid and gasimpermeable material. For example, the front and back sheets 114 and 115may be made from a polymer film and/or a metal film. In one embodiment,the material may be a polymer/metal laminate, such as a polymer/aluminumlaminate.

The front sheet 114 and back sheet 115 may be sealed to each other todefine a cavity for holding the catheter 112. In one embodiment, thefront sheet 114 and back sheet 115 may be sealed to each other to form agas tight cavity. In the illustrated embodiment, the front sheet 114 andback sheet 115 are sealed to each other by a peripheral seal 126. Theperipheral seal 126 may be a peelable seal that may be a heat seal, anadhesive seal or any other suitable peelable seal that allows the frontsheet 114 to be separated from the back sheet 115 when the sheets arepeeled apart during use. As illustrated in FIG. 7, the package 100 mayinclude the hydration foam 130 and the device 12.

Turning now to the hydration mediums that may be used in a medicaldevice product to hydrate the medical device. As mentioned above, thehydration medium may include water and mucilage. Optionally, thehydration medium may include other additives and agents, such as apolyols, surface tension reducing agents, osmolality increasing agentsand deep eutectic liquids. The hydration medium hydrates the hydrophiliccoating of the medical device, such as a hydrophilic coating of acatheter. The hydration medium also may form a mucilage containing layerover the hydrophilic coating. The mucilage containing layer assists inenhancing the performance of the medical device. For example, themucilage containing layer may hydrate the hydrophilic material, protectthe hydrophilic material during radiation sterilization, increaselubriciousness, reduce dry-out of the hydrophilic material, increase thetime period for which the hydrophilic material is lubricious, etc.

The hydrophilic medical device may be contained in a package wherein themucilage containing layer is a distinct layer that is in contact with asurface of the hydrophilic material. The hydration medium and mucilagecontaining layer may have thixotropic properties wherein themedium/layer is thick and viscous under a static condition, and then,becomes less viscous and flows when sheared or otherwise stressed.During delivery of the hydration medium to hydrate the hydrophilicmaterial of the medical device, the hydration medium is under stressand, optionally foamed, which results in the hydration medium being lessviscous and in a more liquid or liquid-like state. In this less viscousstate, the medium flows over and covers the hydrophilic material. Afterthe hydration medium has been delivered, the hydration medium is under arelatively more static condition. Under the static condition, thehydration medium forms a layer including mucilage disposed over thehydrophilic material. When the medium is foamed, the layer may form asthe foam coalesces and collapses. During catheterization, the mucilagecontaining layer is placed under shear or other stress, and thehydration medium/layer becomes less viscous and flows easier. Forexample, when the catheter is inserted into a urethra, the hydrationmedium/layer is placed under shear stress and the hydration medium/layerbecomes less viscous and flows.

This thixotropic property of the medium/layer provides a hydrationmedium/layer that has an anti-gravity effect in that the layer tends toremain in place on the surface of the hydrophilic material of thedevice, when it is in a static condition, regardless of the device'sorientation. Thus, the layer tends to remain over and hydrate thehydrophilic material of the device regardless of the orientation of thedevice during storage. This allows the device to be stored in anyorientation, e.g. vertical, horizontal, etc. This assists in maintaininguniform hydration of the hydrophilic material during storage, whichassists in the device being ready to use right out of the package.

Turning to FIGS. 8 and 9, a mucilage containing layer 132 formed fromthe hydration medium may be disposed over the hydrophilic coating 134,which is one a catheter tube 136. The hydrophilic coating 134 may havebeen pre-hydrated with a hydration medium, such as water or saline.Pre-hydration may include exposing the hydrophilic coating 134 tohydration medium by dipping, spaying or immersing the hydrophiliccoating 134 in liquid water or saline. In another embodiment, thehydrophilic coating 134 may be hydrated by the mucilage containing layer132 after hydration medium has been disposed over the coating. Themucilage containing layer 132 may be disposed over the hydrophiliccoating 134, by dipping or immersing the hydrophilic coating 134 in abath of water and mucilage. In another embodiment, hydration mediumcontaining mucilage may be placed in the package 100 with the catheter112 (FIG. 5) or may be placed into the sleeve 22 containing the cathetershaft 12 (FIG. 1). As mentioned above, the hydrophilic coating 134 maybe pre-hydrated and/or may be hydrated by the mucilage containing layer132.

It should be understood that the mucilage containing hydration mediumforms a layer on the hydrophilic device. As such, the mucilagecontaining hydration medium and the layer include the same or similarcomponents. The mucilage in the mucilage containing hydrationmedium/layer 132 may include one or more exopolysaccharide. They mayalso include a polar glycoprotein. The mucilage of the hydrationmedium/layer 132 may be derived from one or more of aloe vera, basellaalba, cactus, Chondrus crispus, corchorus, Dioscorea polystachya,Chinese yam, drosera, Drosophyllum lusitanicum, flax seeds, kelp,liquorice root, marshmallow, mallow, mullein, okra, parthenium,pinguicula, psyllium seed, Salvia hispanica seed, Talinum triangulare,Ulmus rubra bark, and Plantago major.

Furthermore, the mucilage may contain an exopolysaccharide that isderived from bacteria. The exopolysaccharides may include, but are notlimited to one or more of acetan, alginate, cellulose, chitosan,curdlan, cyclosophorans, dextran, emulsan, galactoglucopolysaccharides,galactosaminogalactan, gellan, glucuronan, N-acetylglucosamine,N-acetyl-heparosan, hyaluronic acid, indicant, kefiran, lentinan, levan,pullulan, scleroglucan, schizophyllan, stewartan, succinoglycan,xanthan, welan or derivatives thereof.

The mucilage containing hydration medium/layer may include othercompositions, additives or agents. Optionally, the mucilage containinghydration medium/layer may include water, saline, and/or oil. The oilmay include but is not limited to vegetable oil, such as rapeseed oil,olive oil, sunflower oil, mustard oil, vegetable oil etc. Optionally,the mucilage containing hydration medium/layer may also include apolyol. The polyols include but are not limited to one or more ofglycerol and polyethylene glycol. In one embodiment, the mucilagecontaining hydration medium/layer includes glycerol.

Optionally, the mucilage containing hydration medium/layer may furtherinclude a surface tension reducing agent, such as a surfactant. When thehydration medium is foamed, the surface tension reducing agent mayassist in the foaming of the hydration medium. Surfactants include, butare not limited to, one or more of saponified coconut oil, vitamin E,polyoxyethylene sorbitan monolaurate, sodium dodecyl sulfate, tween 20,tween 80, polysorbate, L-α-phosphatidylcholine, lecithin, stearylstearate, sodium stearate, sodium laurate, sodium myristate, sodiummyristate, sodium palmitate, sodium oleate, polyethylene glycolmonododecyl ether, glycolic acid ethoxylate lauryl ether, glycolic acidethoxylate oleyl ether, ethylene glycol monododecyl ether,polyoxyethylene glycerol ester, polyglyceryl esters, diglyceryldiisostearate, diglyceryl monolaurate, diglyceryl monooleate, Docusatesodium, dioctyl sulfosuccinate sodium salt, dioctyl sodiumsulfosuccinate, sodium dodecylbenzenesulfonate, perfluorobutane sulfonicacid, 3-sulfopropyl ethoxylate lau-rylphenly ether, lauric acid sodiumsalt, N-acylsarcosine sodium salt, N-lauroylsarcosine sodium salt. Whenthe mucilage containing hydration medium is foamed, the mucilage mayserve as a foam stabilizer that slows coalescence of the foam.

In one embodiment, the mucilage containing hydration medium/layer maycontain about 0.01 wt % to about 10 wt % mucilage, with the balancebeing water and, optionally, other additives and agents. The mucilagecould be at least about 5 wt % of the hydration medium/layer. In anotherembodiment the mucilage is less than about 0.5 wt % of the hydrationmedium/layer. As mentioned above, the mucilage containing hydrationmedium/layer may include other components as well. Optionally, themucilage containing hydration medium/layer could include about 90 wt %to about 99.9 wt % water. The water could be at least about 95 wt % ofthe hydration medium/layer. In another embodiment, the water could beless than about 99.5 wt %. Optionally, the mucilage containing hydrationmedium/layer could include oil at between about 0.05 wt % and about 5 wt%. The oil could be at least about 1 wt % of the medium/layer. Inanother embodiment the oil could be less than about 0.2 wt %.Optionally, the mucilage containing hydration medium/layer could includeabout 0.1 wt % to about 9.2 wt % polyol. The polyol could be at leastabout 4.6 wt % of the medium/layer. In another embodiment, the polyolcould be less than about 1 wt %. Optionally, the mucilage containinghydration medium/layer could include about 0.05 wt % to about 2 wt % ofa surfactant. The surfactant could be at least about 0.5 wt % of themedium/layer. In another embodiment the surfactant could be less thanabout 0.1 wt %.

In one exemplary embodiment, the mucilage containing hydrationmedium/layer could include:

Mucilage  1.1 wt % to 5.1 wt % Water 98.5 wt % to 94.9 wt % Polyol   1wt % to 4.6 wt % Surfactant  0.1 wt % to 0.5 wt %

In one embodiment, the mucilage containing hydration medium/layer mayinclude xanthan gum in an amount between about 0.1 wt % and about 1 wt%, optionally, a surfactant (such as Sodium Methyl Cocoyl Taurate) in anamount between about 0.05 wt % and about 0.2 wt %, optionally, oil in anamount of between about 0.05 wt % and about 1 wt % and the balance asolution of water and glycerol, wherein the water is at 98 wt % of thesolution and the glycerol is 1 wt % of the solution. It will beunderstood that the water and glycerol could be added to the hydrationmedium/layer separately, at the same ratio, and not as a solution. Thehydration medium/layer could include other components as well, such asantimicrobial, fragrances, epithelial medicates, etc. Optionally, themucilage containing hydration medium/layer could also include anosmolality increasing agent and/or a deep eutectic liquid, such as anyof those discussed below. Optionally, the polyol could serve as anosmolality increasing agent.

Referring to FIG. 9, the hydrophilic coating 134 is deposed on acatheter shaft 136. The mucilage containing hydration medium/layer 132is formed from exopolysaccharide molecules 140 and water droplets 142.Optionally, the hydration medium/layer may include oil droplets 144 anda surfactant (not shown). The mucilage containing hydration medium/layer132 may trap water droplets 146 and provide an ample supply of watermolecules to hydrate, maintain and/or supplement the hydration ofhydrophilic coating 134.

As mentioned above, the mucilage containing hydration medium/layer 132may exhibit thixotropic properties wherein it is in a semi-solid phaseon which any applied shear force turns the mucilage containing layerinto a more liquid phase. The mucilage layer has loose structure ofexopolysaccharide molecules and water droplets, and optionally, oildroplets and surfactant molecules, held together by weak forces (e.g.,Van Der Waal forces) —exhibiting a liquid—semi solid structure andenhancing coating lubricity performance, which aids in lubricity of thecoating 134. Additionally, the mucilage containing hydrationmedium/layer 132 may assist in immobilizing a water layer onto thehydrophilic coating 134 and trapping water droplets 146. The mucilagecontaining hydration medium/layer 132 also may exhibit a semisolid phasewhich upon shearing becomes liquid.

In one embodiment the mucilage containing hydration medium/layer isformed by mixing polyol and water mixture for 30 minutes at 100 rpmagitation. Then mucilage ingredients are added into polyol and watersolution and homogenized at 500-10,000 rpm for 5 to 30 minutes to attainhomogeneous solution. Alternatively, exopolysaccharide can be mixed atslow agitation of 100 rpm with polyol and water solution which is heatedto 40-75° C. for 30 to 120 minutes. Optionally, oil may be added andhomogenized at 500-10,000 rpm to form stable emulsion. Optionally,surfactant is added to homogeneous mucilage solution with or without oiland mixed at low agitating speed of 50-100 rpm for 5-15 minutes.Optionally, a deep eutectic liquid may be added to the solution. Thishomogeneous solution of the hydration medium/layer may be formed into afoam or can be used in an unfoamed state.

The mucilage containing hydration medium/layer may be appliedover/disposed on the coating by injecting mucilage containing solutionor foam into the sleeve or other container surrounding a catheter orinto the package containing the catheter.

The hydrophilic medical device products may also include a hydrophilicmedical device and oil containing hydration medium or layer disposedover the hydrophilic materials of the device. For example, the separatelayer may be formed from a hydration medium contains oil, wherein theoil comprises or is an oil emulsion. As discussed in more detail below,the hydrophilic materials may be a hydrophilic coating on the surface ofthe medical device and the oil containing hydration medium/layer, whichis separated from the hydrophilic coating, may be disposed over,disposed on and/or superimposed over the hydrophilic coating.

The oil containing hydration medium/layer may enhance the performance ofthe medical device. For example, the oil containing hydrationmedium/layer may hydrate the hydrophilic material, protect thehydrophilic material during radiation sterilization, increaselubriciousness, reduce dry-out of the hydrophilic material, increase thetime period for which the hydrophilic material is lubricious, etc.

The oil containing hydration medium/layer may include a hydration liquidthat may be any hydration liquid that hydrates, activates or wets thehydrophilic material thereby rendering it lubricious. They hydrationliquid may be liquid water or saline.

Turning to FIG. 10, an oil containing hydration medium/layer 150 may bedisposed over the hydrophilic coating 134, which is on a catheter shaft136. The hydrophilic coating 134 may have been pre-hydrated with ahydration liquid, such as water or saline. Pre-hydration may includeexposing the hydrophilic coating 134 to hydration liquid by dipping,spraying or immersing the hydrophilic coating 134 in liquid water orsaline. In another embodiment, the hydrophilic coating 134 may behydrated by the oil containing hydration medium/layer 150 after layer150 is disposed over the coating. The oil containing hydrationmedium/layer 150 may be disposed over the hydrophilic coating 134, bydipping or immersing the hydrophilic coating 134 in a bath of ahydration liquid including oil, wherein the oil has formed an oilemulsion. In another embodiment, a hydration liquid containing oil maybe placed in the package with the catheter (FIG. 5) or may be placedinto the sleeve containing the catheter shaft (FIG. 1). As mentionedabove, the hydrophilic coating 134 may be pre-hydrated and/or may behydrated by the oil containing layer.

The oil in the oil containing hydration medium/layer 150 may include oneor more essential oils, such as tocopherol, menthol, thymol, carvacroletc. The oil also may be a vegetable oil, such as rapeseed oil, oliveoil, sunflower oil, mustard oil, etc. The oil also may be selected toprovide a fragrance and/or to provide a therapeutic effect or asensation. Oils included in any of the hydration mediums disclosedherein may serve to provide a fragrance and/or to provide a therapeuticeffect or a sensation. For example, oil may be provided to add a fruityscent, such a lemon or strawberry scent, that the user experiences whenthe package is opened.

The oil containing hydration medium/layer may include othercompositions, additives or agents. For example, the oil containinghydration medium/layer may include a polyol, such as one or more ofglycerol and polyethylene glycol. In one embodiment, the oil containinghydration medium/layer includes glycerol. The oil containing layer mayfurther include any of the above-mentioned surface tension reducingagents, such as a surfactant.

In one embodiment, the oil containing hydration medium/layer may containabout 0.01 wt % to about 5 wt % oil, with the balance being water and,optionally, other additives. The oil could be at least about 0.01 wt %of the hydration medium/layer. In another embodiment the oil is lessthan about 5 wt % of the hydration medium/layer. As mentioned above, thehydration medium/layer may include other components as well. Optionally,the hydration medium/layer could include about 80 wt % to about 99.9 wt% water. The water could be at least about 80 wt % of the hydrationmedium/layer. In another embodiment the water could be less than about99.9 wt %. Optionally, the hydration medium/layer could include about0.1 wt % to about 10 wt % polyol. The polyol could be at least about0.01 wt % of the hydration medium/layer. In another embodiment thepolyol could be less than about 1 wt %. Optionally, the hydrationmedium/layer could include about 1 wt % to about 5 wt % of a surfactant.The surfactant could be at least about 1 wt % of the hydrationmedium/layer. In another embodiment the surfactant could be less thanabout 5 wt %.

In one exemplary embodiment, the hydration medium/layer could include:

Oil 0.01 wt % to 5 wt % Water   80 wt % to 98.8 wt % Polyol (optionally)  1 wt % to 10 wt % Surfactant (optionally) 0.01 wt % to 5 wt %

In one embodiment, the hydration medium/layer may include an essentialoil or a vegetable oil in an amount between about 0.01 wt % and about 5wt %, a surfactant, such as Sodium Methyl Cocoyl Taurate, in an amountbetween about 0.01 wt % and about 5 wt %, and the balance a solution ofwater and glycerol. In one embodiment, the water is between about 89 wt% and 98.8 wt % of the solution and the glycerol is 1 wt % of thesolution. It will be understood that the water and glycerol could beadded to the hydration liquid/layer separately, at the same ratio, andnot as a solution. The layer could include other components as well,such as antimicrobial, fragrances, epithelial medicates, etc.

Turning back to FIG. 10, the hydrophilic coating 134 is deposed on acatheter shaft 136. The layer 150 is formed from the hydration liquidwhich includes water droplets 152, oil droplets 154, and surfactant 156.The oil and surfactant produces an emulsion. The rate of homogenizationwill determine the size of oil droplets and smaller the droplet sizemore stable is the emulsion coupled with surfactant composition. The oilcontaining layer 150 may trap water droplets 158 and provide an amplesupply of water molecules to hydrate, maintain and/or supplement thehydration of hydrophilic coating 134. In one embodiment the size of theoil droplets may be between about <1 μm and about 100 μm. In anotherembodiment the size of the oil droplets may be at most <1 μm to 10 μm.

The oil containing hydration medium may be applied over/disposed on thecoating by injecting the oil containing solution into a pack containinga catheter or into a sleeve or other container surrounding a catheter.The hydration medium forms a layer over the hydrophilic coating.

As mentioned above, the hydration medium, optionally, may include a deepeutectic liquid. The deep eutectic liquid could also be included in thehydrophilic coating and/or the formulation that forms the hydrophiliccoating.

Deep eutectic liquids are a mixture or blend of two or more compoundswherein the melting point of the deep eutectic liquid is substantiallylower than the melting points of the individual compounds. Deep eutecticliquids have been described as the result of intermolecular hydrogenbonds between the compounds, which at a certain molar ratio leads to astrong depression in the melting point as compared to that of theindividual components. Deep eutectic liquids are typically liquid atroom temperature (˜23° C.).

The components of deep eutectic liquids may include salts, sugars, sugaralcohols, polyols, organic acids, amino acids, and amines. The deepeutectic liquids may be natural or synthetic. In one deep eutecticliquid, the liquid includes a halide salt and a hydrogen bond donor. Thehalide salt may be, for example, one or more of quaternary ammoniumhalide salt, choline chloride, acetylcholine chloride, betaine,tetrabutylammonium chloride, and 2-(diethylamino)ethanol chloride. Thehydrogen bond donor may be one or more alcohols, carboxylic acid, sugar,polyol, amines and amides. For example, the hydrogen bond donor may beone or more of urea, 1,3-dimethylurea, methylurea, glycerol, trehalose,mannose, ethylene glycol, D-xylose, D-glucose, oxalic acid, succinicacid and citric acid. In one embodiment, the deep eutectic liquid mayinclude choline chloride and urea. The molar ratio of choline chlorideto urea may be about 1:2.

In another embodiment, the deep eutectic liquid may include a sugar anda polyol. For example, the sugar may be mannose or trehalose and thepolyol may be glycerol. The deep eutectic liquid may be for exampletrehalose and glycerol at a molar ratio between about 1:30 to about1:550 molar ratio. In one embodiment the molar ratio is 1:30. When usedin hydration medium or in a hydrophilic coating, which may contain othercomponents, the molar ratio between the components trehalose andglycerol in the medium or the coating may be about 1:30 to about 1:550,including all of the ratios therebetween. In one embodiment the molarratio is 1:30, and in another embodiment the ratio is greater than 1:30.In other embodiments, the molar ratio of these components is about 1:20to about 1:1000. In yet another embodiment the molar ratio is about 1:30to about 1:550. In another embodiment, the molar ratio may be 1:100 orgreater.

The deep eutectic liquid may be contained in the hydrophilic materialand/or in the hydration medium. The deep eutectic liquid may enhance theperformance of the catheter. For example, the deep eutectic liquid,whether in the coating or the in the hydration medium, may enhance thelubricity of the hydrophilic material, may result in a smoother textureon the surface of the hydrophilic coating and/or may reduce the risk ofdamage to the catheter coating due to exposure to temperature and/orclimate change.

Regarding a smoother feeling texture on the surface of the hydrophiliccoating. Urinary catheters are inserted and advanced through the urethraof the user to drain the bladder. During advancement and withdrawal ofthe urinary catheter, the outer surface of the hydrophilic materialcontacts and slides against the wall of the urethra. Having a smoothersurface texture may reduce the risk of irritation to the urethral wall.Additionally, because the catheter is being inserted into an intimatepart of the body, some users may feel more comfortable with inserting acatheter having a smoother surface or texture than rougher one.

Regarding exposure to temperature changes, users of intermittent urinarycatheters can self-catheterized around six times a day or more. Becauseof this, catheter users usually carry a supply of catheters with them.In colder climates, the catheters may be exposed to temperatures belowfreezing. In some instances, exposure to colder temperatures mayincrease the risk of damage to the hydrophilic coating of the catheter.The addition of deep eutectic liquids to the catheter assembly may serveas a cryoprotectant that reduces the risk of damage to the catheter whenexposed to cold temperatures.

As mentioned above, a urinary catheter may have a hydrophilic coatingwherein the deep eutectic liquid is incorporated or impregnated in thehydrophilic coating. For example, a hydrophilic coating may includepolyvinylpyrrolidone and the deep eutectic liquid, such as a deepeutectic liquid including trehalose and glycerol. The deep eutecticliquid may be included in the hydrophilic coating formulation that isused to form the hydrophilic coating. Alternatively, the hydrophiliccoating may be formed and then impregnated with the deep eutectic liquidby, for example, immersion of the coating into the deep eutectic liquidor a solution containing the deep eutectic liquid. The amount of thedeep eutectic liquid in the hydrophilic coating may be 0.1 wt %-15 wt %by weight. In other embodiments the deep eutectic liquid may be morethan 15 wt %. In one embodiment, the deep eutectic liquid in thehydrophilic coating may be a trehalose:glycerol complex at any of theabove discussed molar ratios. In one embodiment, the trehalose:glycerolcomplex may be between about 8 wt % and 12 wt % of the coating. Inaddition to the deep eutectic liquid, the hydrophilic coating mayinclude other agents or additives as well. Incorporating the deepeutectic liquid within the hydrophilic coating may be useful in thesituation wherein the hydration medium is a liquid or a vapor and thehydrophilic coating is vapor or liquid hydrated.

As also mentioned above, the hydration medium may contain a deepeutectic liquid. In one embodiment, the hydration medium may includeliquid water and a deep eutectic liquid. The hydration medium mayinclude other additives and agents, as well. The amount of liquid waterin the hydration medium may be at least about 75 wt %. In oneembodiment, the amount of water may be between about 75 wt % and about99 wt %. The amount of deep eutectic liquid in the hydration medium maybe about at least 1 wt %. In one embodiment, the amount of deep eutecticliquid may be between about 1 wt % and about 20 wt %. For example, thehydration medium may include about 80 wt % to about 99 wt % liquid waterand about 1 wt % to about 20 wt % deep eutectic liquid, such astrehalose/glycerol at any of the above discussed molar ratios. Thehydration medium may include other agents and additives as well.

In one embodiment, the hydration medium may be made by combining 95.4 wt% of water, 0.15 wt % Trehalose dehydrate, 1.095 wt % of Glycerol andadding 3.355 wt % of Glycerol. In another embodiment, the hydrationmedium may be made by combining 95.4 wt % water, 1.254 wt %Trehalose:Glycerol (at 1:30 molar ratio) and adding 3.355 wt % Glycerol.In yet another embodiment, the hydration medium may be made by combining95.4 wt % of water, 0.55 wt % Trehalose dehydrate and adding 4.05 wt %of Glycerol. The hydration medium may include other agents or additivesas well. For example, the hydration medium, optionally, may also includeany the above disclosed surface tension reducing agents. When thehydration medium is a foamed hydration medium, the surface tensionreducing agents may assist in foaming the hydration medium. Thehydration medium, optionally, may also include mucilage.

Optionally, the hydrophilic medical device assembly may include anantifreeze protein (AFP). The antifreeze protein may be incorporatedinto the hydrophilic material and/or may be incorporated into any of thehydration mediums disclosed herein. Antifreeze proteins, sometimesreferred to as ice binding proteins, are ice-restructuring proteincompounds that have an affinity for ice. It is believed that antifreezeproteins disrupt hydrogen bonding during the formation and/or buildup ofice crystals, thereby preventing formation and/or buildup of larger icecrystals. When an ice front is in equilibrium with a solution, slightundercooling of the solution below the equilibrium freezing point allowswater molecules to join the ice lattice. Consequently, the ice frontwill advance. Generally, solutes including the vast majority of proteins(such as bovine serum albumin and myoglobin) will be excluded and pushedahead of the growing ice front. Anti-freeze proteins behave differentlysince they are adsorbed into the ice (Raymond & DeVries 1977). Theentrained AFPs restrict the growth of the ice front to regions betweenthe adsorbed protein molecules.

The antifreeze proteins may include antifreeze glyco proteins (AFGP),which display many disordered saccharide OH groups. Additionally, theantifreeze protein may be natural or synthetic. The antifreeze proteinmay be derived from one or more of an animal, plant, insect andmicroorganism.

The medical device assembly may include antifreeze proteins as acryoprotectant to reduce the risk of damage to the catheter when thecatheter is exposed to cold temperatures.

In one embodiment, the antifreeze protein may include protein compoundshaving a sugar group attached thereto. The protein may includethreonine, alanine, serine, lysine, asparagine, leucine, valine and/orother amino acids. Suitable antifreeze proteins include, but are notlimited to, AFGP, AFP Type I, AFP Type II, AFP Type III, AFP Type IV,and/or other natural or synthetic antifreeze proteins.

As mentioned above, a urinary catheter may have a hydrophilic coatingwherein the antifreeze proteins are incorporated or impregnated in thehydrophilic coating. For example, a hydrophilic coating may includepolyvinylpyrrolidone and the antifreeze proteins. The antifreezeproteins may be included in the hydrophilic coating formulation that isused to form the hydrophilic coating. The amount of the antifreezeproteins in the hydrophilic coating formulation may be about 0.05 wt %to about 2.0 wt %. Alternatively, the hydrophilic coating may be formedand then impregnated with the antifreeze proteins by, for example,immersion of the coating into a solution that includes antifreezeproteins. In addition to the antifreeze proteins, the hydrophiliccoating may include other agents or additives as well. Incorporating theantifreeze proteins within the hydrophilic coating may be useful in thesituation wherein the hydration medium is water vapor and thehydrophilic coating is vapor hydrated.

As also mentioned above, the hydration medium may contain antifreezeproteins. In one embodiment, the hydration medium may include liquidwater and antifreeze proteins. The hydration medium may include otheradditives and agents, as well. The amount of liquid water in thehydration medium may be at least about 90 wt %. In one embodiment, theamount of liquid water may be between about 95 wt % and about 99.9 wt %.The amount of antifreeze proteins in the hydration medium may be aboutat least 0.1 wt %. In one embodiment, the amount of antifreeze proteinsmay be between about 0.1 wt % and about 10 wt %. For example, thehydration medium may include about 95 wt % to about 99.9 wt % water andabout 5 wt % to about 0.1 wt % antifreeze proteins. The hydration mediummay include other agents or additives as well. For example, thehydration medium, optionally, may also include any the above disclosedsurface tension reducing agents. When the hydration medium is a foamedhydration medium, the surface tension reducing agents may assist infoaming the hydration medium. The hydration medium, optionally, may alsoinclude mucilage.

In yet another embodiment of a hydrophilic medical device assembly, theassembly may include a package including a cavity, wherein the cavitycontains a hydrophilic medical device, a hydration medium, and cornsyrup. The corn syrup may be incorporated into the hydrophilic coatingand/or any of the hydration mediums disclosed herein.

For example, a hydrophilic coating may include polyvinylpyrrolidone andthe corn syrup. The corn syrup may be included in the hydrophiliccoating formulation that is used to form the hydrophilic coating. Theamount of the corn syrup in the hydrophilic coating formulation may beabout 0.2 wt % to about 2 wt %. Alternatively, the hydrophilic coatingmay be formed and then impregnated with corn syrup by, for example,immersion of the coating into a solution that includes corn syrup. Inaddition to the corn syrup, the hydrophilic coating may include otheragents or additives as well. Incorporating the corn syrup within thehydrophilic coating may be useful in the situation wherein the hydrationmedium is a vapor and the hydrophilic coating is vapor hydrated.

As also mentioned above, the hydration medium may contain corn syrup. Inone embodiment, the hydration medium may include liquid water and cornsyrup. The hydration medium may include other additives and agents, aswell. The amount of water in the hydration medium may be at least about90 wt %. In one embodiment, the amount of water may be between about 95wt % and about 99.5 wt %. The amount of corn syrup in the hydrationmedium may be about at least 0.5 wt %. In one embodiment, the amount ofcorn syrup may be between about 0.5 wt % and about 10 wt %. For example,the hydration medium may include about 95 wt % to about 99.8 wt % waterand about 5 wt % to about 0.2 wt % corn syrup. The hydration medium mayinclude other agents or additives as well. For example, the hydrationmedium, optionally, may also include any the above disclosed surfacetension reducing agents. When the hydration medium is a foamed hydrationmedium, the surface tension reducing agents may assist in foaming thehydration medium. The hydration medium, optionally, may also includemucilage.

Hydration Foam

As discussed above, any of the hydration mediums disclosed herein may beemployed in a foamed or unfoamed state. When the hydration medium isfoamed or employed as a hydration foam, the foam includes gas bubbles onor in a liquid. The hydration medium may be foamed or formed into a foamin any suitable manner. For example, the foam may be formed byhomogenizers, mixtures or agitators. The foam also could be foamed byaerosol and/or chemical reaction. The foam also could be formed byphysical shaking of the medical product/package. For example, the enduser could shake the package to form the hydration liquid into ahydration foam. Furthermore, the creation or formation of the hydrationfoam may occur at any of the various stages from manufacture to use,depending on the design and use of the medical device.

The hydration foam may include a hydration liquid and a mass of bubblesformed on or in the hydration liquid. The bubbles may be formed from anyvarious gases, and in one embodiment, the bubbles are formed fromambient air. The bubbles may have an average size between 1 μm and 100μm. In one embodiment the average bubble size is less than 1 μm.Optionally, the hydration liquid to gas ratio is about 1 to 7 to about 4to 7 by volume.

The hydration liquid may be water, an aqueous solution or other suitableliquid or solution. When the hydration liquid includes water or anaqueous solution, the water may be de-ionized. The hydration foam may beformed by any suitable foaming techniques, such agitation, blowing,homogenization, aerosol, shaking, etc.

In one embodiment, the hydration liquid of the hydration foam may be asolution that includes the liquid for hydrating the device (e.g., water)along with additives and agents. The solution may include a liquid(e.g., water) at between 80 wt % and 99 wt % of the solution with thebalance being any suitable additives and agents, such as those discussedherein. In another embodiment, the hydration liquid is greater than 80wt % of the solution with the balance being additives and agents. In afurther embodiment, the liquid is greater than or equal to about 90 wt %of the hydration medium.

In one embodiment, the hydration liquid, and thus the hydration foam,may include a surface tension reducing agent, which may assist in addingor incorporating gas bubbles into the hydration liquid to form thehydration foam. The surface tension reducing agent may be a foamingagent. In one embodiment, the surface tension reducing agent may be asurfactant or a mixture of surfactants. Furthermore, the surface tensionreducing agent may be ionic or non-ionic. Examples of surface tensionreducing agents include, but are not limited to, one or more ofsaponified coconut oil, vitamin E, polyoxyethylene sorbitan monolaurate,sodium methyl cocoyl taurate, sodium dodecyl sulfate, tween 20, tween80, polysorbate, L-α-phosphatidylcholine, lecithin, stearyl stearate,sodium stearate, sodium laurate, sodium myristate, sodium myristate,sodium palmitate, sodium oleate, polyethylene glycol monododecyl ether,glycolic acid ethoxylate lauryl ether, glycolic acid ethoxylate oleylether, ethylene glycol monododecyl ether, polyoxyethylene glycerolester, polyglyceryl esters, diglyceryl diisostearate, diglycerylmonolaurate, diglyceryl monooleate, Docusate sodium, dioctylsulfosuccinate sodium salt, dioctyl sodium sulfosuccinate, sodiumdodecylbenzenesulfonate, perfluorobutane sulfonic acid, 3-sulfopropylethoxylate lau-rylphenly ether, lauric acid sodium salt,N-aclylsarcosine sodium salt, N-lauroylsarcosine sodium salt.

The surface tension reducing agents may also provide health benefits tohuman tissue that come into contact with the hydrated device. Forexample, in a hydrophilic urinary catheter, the surface tension reducingagent may also serve to provide health benefits to the urinary tract,the stratum corneum and/or the bladder. Furthermore, the surface tensionreducing agent may be in an amount of between about 0.05 wt % and about5 wt % of hydration foam, which the balance being water and, optionally,other additives. In one embodiment, the hydration medium may includewater at between about 95 wt % and 95.5 wt % and a surface tensionreducing agent between about 0.05 wt % and about 5 wt %.

The hydration liquid, and thus the hydration foam, may also include aviscosity increasing agent that increases the viscosity of the hydrationliquid within the foam. Examples of viscosity increasing agents include,but are not limited to, glycerol, polyethylene glycol, sugar alcohols,polyols, sugars, soluble polymers including polysaccharides,polyvinylpyrrolidone, polyethylene oxide, cationic or anionicpolyelectrolytes including polyampholytes. Furthermore, the viscosityincreasing agent may be in an amount between about 0.05 wt % and about10 wt % of the liquid forming the hydration foam.

The hydration liquid, and thus the hydration foam, optionally, may alsoinclude a foam stabilizer that stables the foam, e.g., slows coalescenceof the foam and release gas. Examples of foam stabilizers include by arenot limited to Xanthan gum, guar gum, galactomannans, glucomannans,agar, carrageenan gum, polysaccharides. The foam stabilizer may be in anamount between about 0.01 wt % and about 5 wt % of the liquid formingthe hydration foam. Optionally, the foam stabilizer may be any of theabove-discussed mucilage compounds. When the hydration foam includes amucilage compound, after the gas has been released from the foam, thehydration foam may form a mucilage layer over the hydrophilic materialof the medical device, as discussed above.

In one embodiment, the hydration liquid that forms the foam may includeabout 0.05 wt % to 5 wt % of a surfactant (e.g., sodium dodecyl sulphateor sodium methyl cocoyl taurate), about 0.5 wt % to 10 wt % of aviscosity increasing agent (e.g., a polyol, such as glycerol), about 80wt % to 99.0 wt % liquid for hydrating the device (e.g., water orde-ionized water), and about 0.01 wt % to 2 wt % stabilizer (e.g.,Xanthan gum). In one embodiment, the hydration liquid that forms thefoam may include about 0.1 wt % sodium dodecyl sulphate (SDS) or sodiummethyl cocoyl taurate (SMCT), about 0.2 wt % xantham gum, about 1 wt %glycerol and about 98.7 wt % water. Optionally, the hydration liquid mayalso include about 0.1 wt %-15 wt % of a deep eutectic liquid orcomponents that form a deep eutectic liquid. Also optionally, thehydration liquid may include between about 0.01 wt % and about 0.3 wt %trehalose, such a Trehalose dehydrate. When the foam is formed from theliquid, the balance of the foam is a gas. In one embodiment, the liquidthat forms the hydration foam includes:

Water   80 wt % to 99.5 wt % Surfactant (SMCT) 0.01 wt % to 5 wt %Polyol (glycerol)  0.1 wt % to 10 wt % Stabilizer (Mucilage, Xanthangum) 0.01 wt % to 2 wt % DEL Forming Additive (Trehalose) (optional)0.01 wt % to 2 wt %The above liquid could be used in a foamed or unfoamed state.

In one method of making a foam, the surface tension reducing agent(e.g., sodium dodecyl sulphate), viscosity increasing agent (e.g.,glycerol) and hydration liquid (e.g., water) are homogenized to form afoam. The foam may be for example at a about a 1 to 7 to about a 2 to 7ratio in volume liquid to air bubbles or have foam density of 0.1 to 0.5g/cm³. The ratio or foam density may be higher or lower depending onpackage or sleeve size. Optionally, a foam stabilizing agent (e.g.,mucilage, such as Xanthan gum) may be added and the foam may again behomogenized. The formation of the foam may be carried out at 23° C. Inother embodiments, the formation may be carried out at higher or lowertemperatures depending on the desired foam. For example, certain surfacetension reducing agents readily create more bubbles at highertemperatures.

As described in more detail below, after the hydration foam is formed,it may then be placed in a package with a device, such as a hydrophilicurinary catheter assembly. The foam may include a density and fluidcontent tailored to fill the void of the package or other spacecontaining the device, such that the required mass of fluid may bedistributed evenly along the device. For example, the foam may betailored to be distributed along the full length of a hydrophilicurinary catheter so that the catheter may be uniformly hydrated.Additionally, the foam also may allow for a sufficient amount ofhydration liquid to be placed in the package without having to includeexcess hydration liquid. In one embodiment, the foam may be stable forabout 4 hours or greater than 4 hours. That is, it may take about 4hours for the foam to start to dissipate. In other embodiments, the foammay be stable for a longer or shorter time period.

Furthermore, using a hydration foam has some advantages. For example,the foam is visually perceivable and it is easily to observe duringmanufacturing of the product. For instance, it is easy for a person orelectronic eye to visually observe the amount and location of foamduring manufacturing. Additionally, because the foam occupies a greatervolume than liquid alone, using a foam results in less liquid being usedto hydrate a given surface area or device. Also, because the foameventually dissipates, it is not visible or readily perceived by the enduser. Optionally, the foam may not dissipate and is visible to the enduser.

FIGS. 11-14 illustrate hydration foam forming and delivery systems.Turning to the system 200 illustrated in FIG. 11, the system 200includes or is fed a supply of a hydration liquid 202, which may be anysuitable hydration liquid, such as those described herein. A pump 204in-line with the supply of hydration liquid 202 pumps the hydrationliquid through a flow meter 206, which meters the flow of the hydrationliquid. The system 200 also includes or is fed a supply of gas 208,which may be for example ambient air, nitrogen or a mixture of both. Thegas also may be any other suitable gas. The gas flows through a pressureregulator 210 and a flow meter 212. The gas then flows through asintered nozzle 214 where it is mixed with the hydration liquid. Asrepresented at 216, the flow meter 206 and flow meter 212 may be incommunication with each other and may be adjusted as needed to regulatethe amount of hydration liquid and amount of gas being mixed. The gasand hydration liquid then flow through a homogenizer 218 to induce theforming of the foam. A recirculation loop around homogenizer maybeincluded to increase homogenization tendency i.e., breakdown of air/gasbubbles. The foam is then metered out or dosed by a metering/dosing pump220. A sampling point or port 222 may be located between the homogenizer218 and metering/dosing pump 220. The port 222 may include a valve 223for opening and closing the port. The dose of foam is delivered orinjected into a catheter package or sleeved catheter assembly by adispensing member 224, such as a docketing nozzle, port or needle.

Turning to the system 226 illustrated in FIG. 12, the system 226includes or is fed a supply of a hydration liquid 228. A metering ordosing pump 230 in-line with the supply of hydration liquid 228 pumps adose of the hydration liquid into a pressure chamber 232. The system 226also includes or is fed a supply of gas 234, which may be for example,ambient air, nitrogen or a mixture of the two. The gas also may be anyother suitable gas. The gas flows through a pressure regulator 236 and aflow meter 238. The metered gas then flows through a sintered nozzle 240into the pressure chamber 232 where it is mixed with the hydrationliquid. The pressure chamber includes a dispensing nozzle 242 whichinduces the creation of foam when the mixture of gas and hydrationliquid passes therethrough. As represented at 243, the dosing member230, flow meter 238 and dispensing nozzle 242 may be in communicationwith each other and may be adjusted as needed to regulate the amount ofhydration liquid and amount of gas being mixed and the amount of foambeing formed. The foam is then dispensed by the dispensing member 244into a medical device assembly, such as a catheter package or a sleevedcatheter assembly.

FIG. 13 illustrates a pressurized vessel 246 for dispensing foam. Thevessel may be pressurized by a gas 247, such as air, nitrogen or amixture of both. The foam 245 may be made by the systems described aboveor any other suitable system. After the foam 245 is formed, it is pumpedinto the pressurized vessel 246. The vessel 246 includes an aerosoldispensing valve 248 and a dispensing member 250 for dispensing the foam245 from the vessel 246 directly into a medical device assembly, such asa catheter package or sleeved catheter assembly. The dispensing member250 may also be configured to deliver foam into a system that injectsthe foam into the package or sleeve. Forming the foam and then placingit into a pressure vessel for delivery allows for the foam to be formedat one location and then dispensed at another location. For example, thefoam may be prepared outside of a clean room and then brought into theclean room in the pressurized dispensing vessel.

Turning to FIG. 14, this figure illustrates a system 252 that may be aclean in place (CIP). The system includes a foam preparation sub-system254 and a foam dispensing sub-system 256. As shown in the drawings, thefoam preparation sub-system 254 may be outside of the clean room ormaybe included in the clean room and the foam dispensing sub-system 256may be located in the clean room. The foam preparation sub-system 254includes or is fed a supply of hydration liquid 258. The hydrationliquid is fed into a mixing vessel 260 that has an agitator 262 to stirit. The agitator 262 may be actuated by a motor 263. The mixing vesselmay also include a pressure indicator 265. The hydration liquid thenflows into an in-line homogenizer 264 which is in communication with thevessel 260. The system also includes or is fed a gas from a supply ofgas 266. The gas is fed into a pressure regulator 268 and then through aflow meter 270. The gas then flows through a flow path 272 and through asintered nozzle 274 into the in-line homogenizer 264. The flow path 272includes a valve 274 to open and close the flow path 272.

The gas and liquid mix in the homogenizer 264 to form a foam. Thehomogenizer 264 is in communication with a re-circulation flow path 276and a dispensing flow path 278. The re-circulation flow path 276recirculates the foam back to the mixing vessel 260 and the dispensingflow path 276 is in communication with dispensing sub-system 256. There-circulation flow path 276 has valve 280 associated therewith and thedispensing flow path 278 has valve 282 associated therewith. When thefoam is re-circulated, the valve 280 in the re-circulation flow path 276is opened and the valve 282 in the dispensing flow path 278 is closed.The foam may be re-circulated through the re-circulation flow path 276any number of desired times until it is sufficient for the desired use.Furthermore, if additional gas is desired during re-circulation, nozzle274 will be opened. If additional homogenization is desired without anyadditional gas form the gas supply 266, nozzle 274 will be closed duringre-circulation. When the foam is ready to be dispensed, the valve 280 inthe re-circulation flow path is closed and the valve 282 in thedispensing flow path 278 is open. The dispensing flow path may alsoinclude a sampling point or port 284 so that the foam may be sampledprior to be dispensed. The sampling port 284 may also include a valve286.

The foam flows through the dispensing flow path 278 to the dispensingsub-system 256. The foam may flow into a vessel 288, which may forexample be similar to the above described pressure, and then to ametering or dosing pump 290. Alternatively, the foam may flow directlyto the metering or dosing pump 290. The metering/dosing pump sends ametered amount or dose of foam to a dispensing member 292. Thedispensing member 292 then dispenses the foam into a medical deviceassembly, such as a package or catheter sleeve.

The system 252, optionally, may include clean in place inlets ports 291and outlet ports 293 that allow the system to be cleaned and flushed.

Turning to FIGS. 15-18, a foam hydration medium 310 (FIG. 16) may beformed within the package 300 through a chemical reaction. In someembodiments, the foam hydration medium 310 may be formed during thepackaging process. In other embodiments, prior to use, the user mayinitiate the reaction that forms the hydration foam 310. The reactionmay be a reaction of two or more chemicals that produce a gas, includingbut not limited to, carbon dioxide, nitrogen, etc. In one embodiment,the reactants may be sodium bicarbonate and citric acid. As explained inmore detail below, the reactants may be in solution and/or in solidform.

FIGS. 15 and 16 illustrate a package 300 that has similar features tothat of package 100 shown in FIGS. 5 and 6. As schematically shown inFIG. 15, during the manufacturing process, the hydrophilic catheter 312is placed in the cavity of the package 300 and the foam formingreactants may be placed into the package just prior to the package beingsealed. The foam forming reactants may be delivered as a solid or asolution. For example, referring to FIG. 15, during packaging ofcatheter 312, a first solution 302 containing a first reactant may bedispensed into the inner cavity of the catheter package 300 through adispensing member or spout 304. A second solution 306 containing asecond reactant may be dispensed into the inner cavity of the catheterpackage 300 through a dispensing member or spout 308. In one embodiment,the total amount of the two solutions dispensed into the package may be4 ml or less. In one example, 2 ml or more of one of the solutions and 2ml or less of the other solution may be dispensed into the package. Inanother example, 3 ml or less of one of the solutions and 1 ml or moreof the other solution may be dispensed into the package.

After the first and second solutions 302 and 306 are dispensed, thepackage is sealed. When the first and second solutions 302 and 306 mix,the first and second reactants react with each other to release a gas tofoam the solutions and form a hydration foam 310. As illustrated in FIG.16, the foam 310 occupies the cavity of the package 300 and hydrates thehydrophilic material of the catheter 312.

In one example, one of the first solution 302 and the second solution306 may be an aqueous solution of water and citric acid and the other ofthe first and second solutions may be an aqueous solution of water andsodium bicarbonate. One or both of the first and second solutions mayinclude a surface tension reducing agent (such as a foaming agent), afoam stabilizing agent, and/or a viscosity increasing agent, such as anyof the agents listed above. For example, the first and/or secondsolution may include sodium dodecyl sulfate, xanthan gum and glycerol.Additionally, the agents in the foam may be in any of the amounts listedabove. In one exemplary embodiment, the first solution may includecitric acid, a tension reducing agent, a foam stabilizing agent, and/ora viscosity increasing agent, and the second solution may include sodiumbicarbonate. In another embodiment, the first solution may includecitric acid and the second solution may include sodium bicarbonate, atension reducing agent, a foam stabilizing agent, and/or a viscosityincreasing agent. In yet another embodiment, the first solution mayinclude citric acid and, for example, sodium dodecyl sulfate, xanthangum, glycerol and water and the second solution may include sodiumbicarbonate and water. Alternatively, the main foaming components of thehydration solution may be reversed as that the first solution mayinclude citric acid and water, and the second solution may includesodium bicarbonate and for example sodium dodecyl sulfate, xanthan gum,glycerol and water. Or further still any mixture of sodium dodecylsulfate, xanthan gum, glycerol and water may be combined with the citricacid solution or with the sodium bicarbonate solution, whilst keepingthe foaming reagents separate.

In another method of making the catheter product, the first and secondreactants may be placed in the package in solid form. They may becombined in one solid form (such as one tablet) or two different solidforms (two tablets or two loose powders). For example, citric acid andsodium bicarbonate may be placed in the package in solid form. When thehydration liquid is dispensed into the package, the solid forms dissolveinto solution and the reactants react to form the hydration foam. Thehydration liquid may include any of the above mentioned agents. Inanother embodiment, one of citric acid or sodium bicarbonate may be insolid form and the other may be in a solution that is dispensed into thepackage.

FIGS. 17-19 illustrate another embodiment of a package 300 a thatincludes a hydrophilic catheter 312 a, a first solution 302 a containinga first reactant and a second solution 306 a containing a secondreactant. The first and second reactants, when mixed, react to produce agas that foams the solutions to form a hydration foam that hydrates thehydrophilic material of the catheter. The reactants may be any of theabove mentioned reactants. Also, the first and/or the second solutionsmay include one or more of a surface tension reducing agent (such as afoaming agent), a foam stabilizing agent, and/or a viscosity increasingagent, such as any of the agents listed above.

The first solution 302 a and the second solution 306 a may be separatedwithin the cavity of the package 300 a until a desired time. In oneembodiment, the first solution 302 a may be loose within the package 300a and the second solution 306 a may be contained within a sealedcompartment 308 a that may be opened at a desired time to allow mixingof the first and second solutions. For example, the compartment 308 amay be burstable or otherwise openable. In the illustrated embodiment,the compartment 308 a is a burstable sachet that may be burst by theapplication of pressure. The sachet may be burst by applying pressure tothe sachet through the package. For example, the sachet may be squeezedbetween the hand or fingers, or between the hand and a stationary object(e.g., table top, user's leg, etc.) the compartment 308 a may be openedduring the manufacturing process or prior to distribution to the user.Alternatively, the compartment may be opened by the user just prior touse.

Referring to FIGS. 18 and 19, when the compartment 308 a is opened, thesolutions mix and the reactants react to form a foam 310 a. For example,when the compartment 308 a is a sachet, the sachet is burst open bypressure to release the second solution 306 a. The second solution 306 amixes with the first solution 302 a and a foam is formed.

FIG. 20 illustrates another embodiment which the reactants are in asolid form 314 b within the package and a hydration liquid 316 b iswithin an openable compartment 308 b. The reactants may be a in a singletablet 318 b, may be in two different tablets or may be in powder form.The hydration liquid 316 b may include one or more of a surface tensionreducing agent (such as a foaming agent), a foam stabilizing agent,and/or a viscosity increasing agent, such as any of the agents listedabove. When the compartment 308 b is opened, the reactants dissolvewithin the hydration liquid 316 b and react to form a gas that foams thehydration liquid to create a hydration foam that fills or occupies thecavity of the package, similar to that shown in FIG. 19.

FIGS. 21-41 illustrate additional systems and methods for deliveringand/or forming a foamed hydration medium within the sleeve or package ofa catheter product. The hydration medium or liquid may be any of thosedisclosed herein.

Turning to FIGS. 21 and 22, similar to FIG. 1, the catheter assembly 10has a sleeve 22 surrounding a catheter 12. Referring to FIG. 22, thesystem for delivering hydration foam into the interior cavity of thesleeve 22 includes an on-demand foaming device that may be used by theend user during the catheterization procedure. The system may include anaerosol container 402 that contains a liquid hydration medium underpressure with air or gas, which may be, but is not limited to, nitrogen,carbon dioxide, nitrous oxide, etc. The aerosol container 402 alsoincludes a release valve 404 that releases the foam 400 from the aerosolcontainer 402. The aerosol container 402 also includes a nozzle 406 thatis configured to dock with, engage or otherwise operatively connect withthe proximal end of the sleeve, or the insertion aid 28, if present. Thenozzle 406 delivers the hydration foam 400 into the sleeve 22.Optionally, the aerosol container 402 also may include a metering devicefor metering the amount or dose of foam dispensed into the sleeve.

In use, the user removes the cap 44 from the catheter assembly 10, if acap is present. The nozzle 406 and proximal end of the sleeve 22 areengaged, and the user opens valve 404 to release the foam 400. Theaerosol container 402 may include a button that when depressed opens thevalve 404. When the compressed liquid and air/gas mixture is releasedfrom the nozzle 406 it results in formation of foam 400. The type offoam and volume can be control by the nozzle type. Optionally, a venturitube or widget within the container or nozzle can form the foam, i.e.,mix the air/gas and liquid compositions. After the foam 400 has beenadded to the sleeve 22, the user waits for the hydrophilic coating to besufficiently hydrated (about 2 minutes). The catheter is then ready foruse.

Turning to FIG. 23, in this embodiment, the aerosol container 402 may beused to deliver foam 400 into package 100, which is similar to thepackage of FIG. 5. In use, the user peels or tears open the package 100and then inserts the nozzle 406 into the opening or connects the nozzle406 to the package 100. Then, the user opens valve 404 to release thefoam 400 and deliver it from the nozzle 406 and into the package 100.

FIGS. 24 and 25 illustrate another embodiment of a foam delivery system410. The system 410 may be a table-top system that is configured to siton a table-top or counter 412. While the aerosol container 402 (FIGS.21-24) provides for portable on-the-go usage, the system 410 may bedesigned for at-home usage. The system 410 could also be configured foron-the-go usage. The system 410 includes a tank 414 for holdinghydration liquid and a foaming device 416. The tank 414 may be arefillable tank or an exchangeable tank. The foaming device 416 mayinclude an agitator or homogenizer that mixes controlled volumes ofliquid and gas to form foam. Optionally, the system may include achamber of gas 418. The chamber of gas 418 also may be refillable orexchangeable. Alternatively, the mixing device 416 may have an ambientair intake (not shown). The tank 414 of liquid and the source of gas 418are connected to the foaming device 416, and the foaming device 416 mayinclude meters and valves to regulate the liquid to gas ratio enteringthe foaming device 416.

Referring to FIG. 24, the system 410 may include a nozzle 420 thatengages or connects with the proximal end of the sleeve 22, or theinsertion aid 28, if present. After the nozzle 420 is engaged, thesystem 410 is activated to deliver foam 400 into the sleeve 22.Referring to FIG. 25, the nozzle 420 may engage the opening of package100 or be inserted into the opening, after which, the system isactivated to deliver foam 400 into the package 100.

Referring to FIGS. 26 and 27, the hydration medium is a liquid 430 thatis saturated or supersaturated with a gas, such as carbon dioxide,nitrogen, nitrous oxide, etc. The saturated/supersaturated liquid isinjected into the sleeve 22 under pressure and the sleeve 22 is sealed.The funnel 20 and cap 44 each may include a removable seal that assistsin making the interior of the sleeve 22 air tight or closed to theambient atmosphere. Opening the interior cavity of the sleeve 22 to theambient atmosphere results in the supersaturated or saturated liquid 430being under atmospheric conditions and a change in pressure. This changefrom a high pressure to a low pressure results in the release of gasfrom the liquid. The released gas foams the liquid to create foam 400,which expands within the sleeve 22 and contacts the catheter. Theinterior cavity of the sleeve may be opened to the atmosphere by removalof cap 44 or removal of the seal from the funnel 20. The volume of foamand its stability are dependent upon pressure, type of gas and liquidvolume.

Referring to FIGS. 28 and 29, a saturated/supersaturated liquid 430 isinjected into the package 100 a under pressure and the package issealed. Opening of the package 100 a, results in the supersaturated orsaturated liquid 430 being under atmospheric conditions and a change inpressure. This change from a high to a low pressure results in theformation of foam 400, as described above. The foam 400 expands withinthe package 100 a and contacts the catheter.

Turning to FIGS. 30 and 31, a compartment 432, such as a sachet, of asaturated/supersaturated liquid 434 is located within the sleeve 22. Theopening of the compartment 432 results in the supersaturated orsaturated liquid 434 being under atmospheric conditions and a change inpressure. This change from a high pressure to a low pressure results inthe formation of foam 400 that expands within the sleeve 22 and contactsthe catheter. The compartment 432 may be opened by any suitable method,such as bursting or tearing. For example, the cap 44 and compartment 432may be configured such that when the cap 44 is removed from theassembly, the compartment 432 is opened. The compartment 432 may includea tear strip that is attached to the inside of the cap 44 such that whenthe cap 44 is removed, it pulls the tear strip and opens the compartment432.

Turning to FIGS. 32 and 33, a compartment 436 of asaturated/supersaturated liquid 434 is located within the package 100 a.The compartment 436 may be opened by any suitable method, such as bybursting or tearing. For example, the compartment 436 and package 100 amay be configured such that when the package 100 a is opened, thecompartment 436 is opened. The compartment 436 may include a tear linethat is in line with a tear line 438 of the package 100 a such that whenthe package 100 a is torn open, the compartment 436 is also torn open.

Turning to FIGS. 34-35 and 36-37, in these catheter products, the foam400 is formed within the sleeve 22 or package 100 a as a result of achemical reaction. Similar to that described above with respect to FIGS.15-18, the reaction may be a reaction of two or more chemicals thatproduce a gas, including but not limited to, carbon dioxide, nitrogen,etc. In one embodiment, the reactants may be sodium bicarbonate andcitric acid, both of which may be in solution and/or in solid form. Ineach of the products, optionally, one of the chemicals is contained in afirst compartment 440 and the other of the chemicals is contained in asecond compartment 442. One of the first and second compartments 440/442includes the chemical in a solution and the other one includes thechemical in solution or solid form. In another embodiment, one of thefirst and second compartments includes both of the chemicals and theother of the compartments includes the hydration liquid.

When the cap 44 is removed from the sleeved assembly in FIGS. 34 and 35or the package 100 a is opened in FIGS. 26 and 37, the first and secondcompartments 440/442 are opened. When the compartments 440/442 open, thechemicals mix in the liquid and form a gas that foams the liquid,resulting in hydration foam 400. The foam 400 expands within the sleeve22 or package 100 a and contacts the hydrophilic coating of the catheterto hydrate the same.

Turning to FIGS. 38-39 and 40-41, in these products, the sleeve 22 orpackage 100 a contains a hydration liquid 450. After the sleeve 22 orpackage 100 a is opened, the user delivers a form foaming solid, such asa tablet 452, into the sleeve 22 or package 100 a. In the sleevedassembly shown in FIGS. 38 and 39, the sleeve 22 includes an opening 454for delivering the tablet 452 into the sleeve 22. In the package 100 ashown in FIGS. 40 and 41, the user delivers the tablet 452 through theopening 456 formed during opening of the package 110 a.

The reactants, such as those discussed above, may be in a single tablet.When delivered into the sleeve or package, the reactants dissolve withinthe hydration liquid and react to form a gas that foams the hydrationliquid to create a hydration foam that fills or occupies the cavity ofthe sleeve or package.

It will be understood that the embodiments described above areillustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims, and it is understood that claims may bedirected to the features hereof, including as combinations of featuresthat are individually disclosed or claimed herein.

1. A urinary catheter product, comprising: a package containing: aurinary catheter having a hydrophilic coating thereon; and a hydrationmedium for hydrating a hydrophilic coating, the hydration mediumcomprising (i) a hydration liquid for hydrating the hydrophilic coating,(ii) a surfactant, (iii) a viscosity increasing agent and (iv) astabilizer.
 2. The catheter product of claim 1, wherein the hydrationmedium comprises: the hydration liquid in an amount between 80 wt % to99.0 wt %; the surfactant in an amount between 0.05 wt % to 5 wt %; theviscosity increasing agent in an amount between 0.5 wt % to 10 wt %; andthe stabilizer in an amount of between about 0.01 wt % and about 5 wt %.3. The catheter product of claim 1, wherein the hydration liquidcomprises water.
 4. The catheter product of claim 3, wherein thehydration liquid comprises a solution wherein water is greater thanabout 80 wt % of the hydration liquid.
 5. The catheter product of claim1, wherein the viscosity increasing agent comprises glycerol,polyethylene glycol, sugar alcohols, polyols, polysaccharides andsugars.
 6. The catheter product of claim 5, wherein the viscosityincreasing agent is in an amount between about 0.1 wt % and about 10 wt% of the hydration medium.
 7. The catheter product of claim 1, whereinthe surfactant is ionic or non-ionic.
 8. The catheter product of claim1, wherein the surfactant comprises one or more of saponified coconutoil, vitamin E, polyoxyethylene sorbitan monolaurate, sodium dodecylsulfate, tween 20, tween 80, polysorbate, L-α-phosphatidylcholine,lecithin, stearyl stearate, sodium stearate, sodium laurate, sodiummyristate, sodium myristate, sodium palmitate, sodium oleate,polyethylene glycol monododecyl ether, glycolic acid ethoxylate laurylether, glycolic acid ethoxylate oleyl ether, ethylene glycol monododecylether, polyoxyethylene glycerol ester, polyglyceryl esters, diglyceryldiisostearate, diglyceryl monolaurate, diglyceryl monooleate, Docusatesodium, dioctyl sulfosuccinate sodium salt, dioctyl sodiumsulfosuccinate, sodium dodecylbenzenesulfonate, perfluorobutane sulfonicacid, 3-sulfopropyl ethoxylate lau-rylphenly ether, lauric acid sodiumsalt, N-acylsarcosine sodium salt, and N-lauroylsarcosine sodium salt.9. The catheter product of claim 7, wherein the surfactant is in anamount of between about 0.01 wt % and about 5 wt % of the hydrationmedium.
 10. The catheter product of claim 1, wherein the stabilizercomprises one or more of xanthan gum, guar gum, galactomannans,glucomannans, agar, carrageenan gum, polysaccharides, andpolyvinylpyrrolidone.
 11. The catheter product of claim 9, wherein thestabilizer is present in an amount between about 0.01 wt % and about 2wt % of the hydration medium.
 12. The catheter product of claim 1,wherein the hydration medium further includes components of a deepeutectic liquid.
 13. The catheter product of claim 1, wherein thehydration medium further comprises trehalose.
 14. The catheter productof claim 1, wherein the hydration medium further comprises acryoprotectant.
 15. A method of making a urinary catheter product,comprising: placing a urinary catheter having a hydrophilic coatingthereon within a package; and placing a hydration medium within thepackage, the hydration medium comprising (i) a hydration liquid forhydrating the hydrophilic coating, (ii) a surfactant, (iii) a viscosityincreasing agent and (iv) a stabilizer.
 16. The method of claim 15,wherein the hydration medium comprises: the hydration liquid in anamount between 80 wt % to 99.0 wt %; the surfactant in an amount between0.05 wt % to 5 wt %; the viscosity increasing agent in an amount between0.5 wt % to 10 wt %; and the stabilizer in an amount of between about0.01 wt % and about 5 wt %.
 17. The method of claim 15, wherein thehydration liquid comprises water.
 18. The method of claim 15, whereinthe viscosity increasing agent comprises glycerol, polyethylene glycol,sugar alcohols, polyols, polysaccharides and sugars.
 19. The method ofclaim 15, wherein the surfactant comprises one or more of saponifiedcoconut oil, vitamin E, polyoxyethylene sorbitan monolaurate, sodiumdodecyl sulfate, tween 20, tween 80, polysorbate,L-α-phosphatidylcholine, lecithin, stearyl stearate, sodium stearate,sodium laurate, sodium myristate, sodium myristate, sodium palmitate,sodium oleate, polyethylene glycol monododecyl ether, glycolic acidethoxylate lauryl ether, glycolic acid ethoxylate oleyl ether, ethyleneglycol monododecyl ether, polyoxyethylene glycerol ester, polyglycerylesters, diglyceryl diisostearate, diglyceryl monolaurate, diglycerylmonooleate, Docusate sodium, dioctyl sulfosuccinate sodium salt, dioctylsodium sulfosuccinate, sodium dodecylbenzenesulfonate, perfluorobutanesulfonic acid, 3-sulfopropyl ethoxylate lau-rylphenly ether, lauric acidsodium salt, N-acylsarcosine sodium salt, and N-lauroylsarcosine sodiumsalt.
 20. The method of claim 15, wherein the stabilizer comprises oneor more of xanthan gum, guar gum, galactomannans, glucomannans, agar,carrageenan gum, polysaccharides, and polyvinylpyrrolidone.